1. Field of the Invention
The present invention relates to a medical container, particularly a medical container for use in instillation. More specifically, the present invention relates to a medical container with multiple chambers, where a plurality of medicaments are housed in multiple chambers, and the respective medicaments are prevented from leaking or mixing until the infusion, and the respective medicaments can be easily mixed at the time of infusion.
2. Description of Related Art
In the case of preparing an infusion medicament by mixing a plurality of medicaments immediately before the administration of the infusion medicament, it is necessary to prevent foreign bodies or miscellaneous bacteria from mixing into the infusion medicament.
An example of a medical container capable of mixing a plurality of medicaments in a sterile environment is a medical container with multiple chambers, where the inner wall surface of a bag container formed of a synthetic resin-made film is heat-sealed and a plurality of medicaments are housed in multiple chambers partitioned by sealed parts within the bag container. According to this medical container with multiple chambers, the sealed part partitioning respective chambers is peeled open to unite the chambers within the container into one chamber, whereby the respective medicaments can be mixed.
In such a medical container with multiple chambers, the medicaments must be separated from each other without fail until the infusion. Therefore, it is required that the sealed part in the medical container with multiple chambers not be readily peeled open as a result of ordinary handling before the infusion, for example, during washing, partial filling or sterilization of the medical container with multiple chambers. On the other hand, it is necessary that, when the sealed part is peeled open, it opens by itself, without damaging the container body.
Examples of medical containers with multiple chambers, of which the fused part satisfies such requirements, have been proposed in Japanese Unexamined Patent Application, First Publication Nos. Sho 63-19149, Hei 1-240469, Hei 2-4671, Hei 6-39018 and Hei 8-24314. The fused part proposed in these patent publications includes a type where the inner surface of a bag container formed of a mixture of two or more kinds of synthetic resins having poor compatibility is thermally bonded to form an easily peelable part, a type where a separate film as a layer having the welding and peeling function is laminated on the inner surface of a container, and a type where the heating and pressurizing conditions from the outer surface are strictly controlled to form a weak seal part.
However, if the adhesion strength in the fused part of these types of fused part is controlled to fall within the range of the desired low adhesion strength, the latitude in selecting the sealing conditions for the fused part becomes very narrow. Accordingly, if the sealing conditions depart from the predetermined range and the adhesion strength attained is less than the desired low adhesion strength, the fused part is likely to show partial peeling as the result of handling before the infusion, for example, during washing, partial filling or sterilization, whereas if the adhesion strength exceeds the objective low adhesion strength, the fused part may not be peeled open when mixing the respective medicaments.
In order to solve these problems, Japanese Unexamined Patent Application, First Publication Nos. Hei 4-364851 and Hei 7-155361 have proposed a medical container with multiple chambers, where a pipe or hollow plug closed at one end is provided in the partition part of each chamber. In this type of medical container with multiple chambers, respective chambers may be communicated to mix the medical solutions by breaking off the pipe or hollow plug in the partition part.
However, the pipe or hollow plug provided in the partition part may be damaged due to folding or the like of the container before the infusion. Furthermore, for forming a pipe or hollow plug which can be easily broken off, the pipe or hollow plug itself must have a small diameter but this requirement is accompanied with a limitation in the flow of a medicament passing through the pipe or hollow plug and a problem arises in that the operation of mixing the medicaments takes time.
One object of the present invention is, accordingly, to provide a medical container with multiple chambers, in which respective medicaments housed in a plurality of chambers can be separated without fail until the infusion and at the time of infusion, these medicaments can be easily mixed while keeping the sterile state. Another object of the present invention is to provide a production method of the medical container with multiple chambers.
More specifically, the medical container with multiple chambers of the present invention is obtained by integrating a plurality of containers each having a chamber for housing a medicament, wherein the medical container has a partitioning member for partitioning the plurality of containers; in the partitioning member, a hollow part for connecting two adjacent containers to allow communication therebetween and a lid for sealing at least one end of the hollow part are formed; and in the connection part between the lid and the partitioning member body, a thin-wall part is formed.
In a preferred embodiment, at least one of the plurality of containers has a chamber for housing a powder medicament, another container has a chamber for housing a liquid medicament, and a heat-seal part is provided between the partitioning member and the chamber for housing a powder medicament, which can be peeled open by the inflow pressure of the liquid medicament.
In another preferred embodiment, the partitioning member is elongated in the width direction of the container and narrow in the thickness direction of the container and both end parts of the partitioning member in the width direction of the container are shaped like the prow of a boat.
In another preferred embodiment, the lid has a ribbon shape and ribs running in the cross direction of the lid are provided on the lid surface in the hollow part side.
In another preferred embodiment, an inclined surface is formed on each lateral surface of the lid to incline from the lateral side to the inner side along the direction toward the hollow part side.
In another preferred embodiment, the partitioning member may have cross sections of any of rhombic, elongated ellipse, and circular shape.
The medical container with multiple chambers of the present invention may also have a construction such that the partitioning member comprises a sealing member having formed therein a hollow part and a lid for sealing one end of the hollow part, and a communicating member in the hollow form joined to the end face of the sealing member in the opening side; the sealing member is provided at the end part of a first container having a chamber for housing a liquid medicament; and the communicating member is provided at the end part of a second container having a chamber for housing a powder medicament.
The method for producing a medical container with multiple chambers containing medicaments according to the present invention comprises inserting a support, from the opening of a partitioning member having formed therein a hollow part and a lid for sealing one end of the hollow part, into the hollow part so as to maintain the shape of the hollow part; inserting the partitioning member into the opening end of a first bag container having a chamber for housing a liquid medicament and a filling port for filling a liquid medicament from the outside of the container into the chamber and being open at the end part opposite the end part having the filling port, so that the opening side of the partitioning member faces the outside of the first container, followed by welding of the first container and the partitioning member; inserting the other end of the partitioning member into the opening end of a second bag container having a chamber for housing a powder medicament and being opened at one end, followed by welding of the second container and the partitioning member; heat-sealing the space between the chamber in the second container and the partitioning member to form a heat-seal part which is peelable by the inflow pressure of a liquid medicament; filling a liquid medicament into the chamber of the first container from the filling port of the first container; sealing the filling port of the first container, followed by high-pressure steam sterilization; opening the end part of a second container opposite the end part welded to the partitioning member, followed by filling of a powder medicament into the chamber of the second container in a sterile room; and sealing the opening end of the second container filled with the powder medicament.
In another embodiment, the method for producing a medical container with multiple chambers containing medicaments of the present invention comprises inserting a support, from the opening of a sealing member having formed therein a hollow part and a lid for sealing one end of the hollow part, into the hollow part so as to maintain the shape of the hollow part; inserting the sealing member into the opening end of a first bag container having a chamber for housing a liquid medicament and a filling port for filling a liquid medicament from the outside of the container into the chamber and being open at the end part opposite the end part having the filling port, so that the opening side of the sealing member faces the outside of the first container, followed by welding of the first container and the sealing member; removing the support inserted into the hollow part of the sealing member; filling a liquid medicament into the chamber of the first container from the filling port of the first container; sealing the filling port of the first container, followed by high-pressure steam sterilization; inserting a support, from the opening of a communicating member having formed therein a hollow part, into the hollow part so as to maintain the shape of the hollow part; inserting the communicating member into the opening end of a second bag container having a chamber for housing a powder medicament and being open at one end part, so that the hollow part of the communicating member allows communication between the interior and the exterior of the chamber of the second container, followed by welding of the second container and the communicating member; removing the support inserted into the hollow part of the communicating member; heat sealing across the width of the second container in the space between the chamber in the second container and the communicating member to form a heat seal part which is peelable by the inflow pressure of a liquid medicament; opening the end part of the second container opposite the end part welded to the communicating member, followed by filling of a powder medicament into the chamber of the second container in a sterile room; sealing the opening end of the second container filled with the powder medicament; and welding the end face of the sealing member of the first container to the end face of the communicating member of the second container, thereby integrating the first container and the second container.
The medical container with multiple chambers of the present invention is obtained by integrating a plurality of containers each having a chamber for housing a medicament and has a partitioning member for partitioning these containers. In the partitioning member, a hollow part connecting two adjacent containers to allow communication therebetween and a lid for sealing at least one end of the hollow part are formed. In the connection part between the lid and the partitioning member body, a thin-wall part is formed. Therefore, respective medicaments housed in a plurality of chambers can be separated without fail until performing the infusion, and at the time of infusion, the respective medicaments can be easily mixed while keeping the sterile state.
In the case where at least one of the plurality of containers has a chamber for housing a powder medicament, another container has a chamber for housing a liquid medicament and a heat-seal part peelable by the inflow pressure of the liquid medicament is provided between the partitioning member and the chamber for housing the powder medicament, the chamber for housing the powder medicament can be improved in its isolation property and the powder medicament housed in the chamber can be insulated from the atmosphere outside the container.
In the case where ribs running in the cross direction of the lid are provided on the hollow part side of the lid, the lid can easily open by a deformation operation applied to the partitioning member and the lid can be prevented from rising to close at the time of mixing of medicaments.
In the case where inclined surfaces inclining from the lateral side to the inner side along the direction toward the hollow part side are formed on the lateral surfaces of the lid, the lid can be prevented from swinging open towards the hollow part side by the deformation operation applied to the partitioning member.
In the case where the partitioning member is elongated in the width direction of the container and narrow in the thickness direction of the container, and each end part of the partitioning member in the width direction of the container is shaped like the prow of a boat, the two sheets of synthetic resin-made films constituting the container can be welded to the partitioning member without generating any gaps.
Furthermore, according to the production method of a container with multiple chambers of the present invention, the container and the partitioning member can be welded without generating any gaps, so that in the medical container with multiple chambers obtained, the respective medicaments housed in a plurality of chambers can be separated without fail until performing the infusion.
In particular, according to the medical container with multiple chambers and the production method thereof, where the partitioning member comprises a sealing member having formed therein a hollow part and a lid for sealing one end of the hollow part and a hollow communicating member joined to the opening side end face of the sealing member, the sealing member being provided at the end part of the first container having a chamber for housing a liquid medicament and the communicating member being provided at the end part of the second container having a chamber for housing a powder medicament, the first container and the second container can be prepared in separate places and medicaments can be filled into respective containers in separate places.